Objective classification of adverse events has been a challenge for the industry. An outcome-based, medically-focused classification framework offers a more robust approach.

Risk ManagementNaveen AgarwalSeptember 11, 20195-point grading scale, clavien-dindo classification, medtech, risk management surgery, surgery, medical device, medical safety, medical risk management, surgical complicationsComment

Cybersecurity is the Next Frontier of Risk Management

As medical devices increasingly become more interconnected with other devices, hospital networks and even smartphones, cybersecurity risks are quite real. Managing these risks is a product life cycle issue because they are continually evolving and may arise due to circumstances not completely foreseen during their development.

Risk ManagementNaveen AgarwalAugust 5, 2019cyber security, medical device, medical device safety, medical device cybersecurity, FDA safety, medical device recallsComment

Lifting the Curtain on Alternate Summary Reports

All ASR data files going back to 1999 are now available on FDA’s website. It is a large data set with over a million individual reports of device related injuries and malfunctions. We have started looking into this data and plan to provide insights that will help all of us better understand this information.